Normal sinus rhythm of the heart begins with the sinoatrial node (or “SA node”) generating an electrical impulse. The impulse usually propagates uniformly across the right and left atria and the atrial septum to the atrioventricular node (or “AV node”). This propagation causes the atria to contract in an organized manner to transport blood from the atria to the ventricles, and to provide timed stimulation of the ventricles. The AV node regulates the propagation delay to the atrioventricular bundle (or “HIS” bundle). This coordination of the electrical activity of the heart causes atrial systole during ventricular diastole. This, in turn, improves the mechanical function of the heart. Atrial fibrillation occurs when anatomical obstacles in the heart disrupt the normally uniform propagation of electrical impulses in the atria. These anatomical obstacles (called “conduction blocks”) can cause the electrical impulse to degenerate into several circular wavelets that circulate about the obstacles. These wavelets, called “reentry circuits,” disrupt the normally uniform activation of the left and right atria.
Because of a loss of atrioventricular synchrony, people who suffer from atrial fibrillation and flutter also suffer the consequences of impaired hemodynamics and loss of cardiac efficiency. They are also at greater risk of stroke and other thromboembolic complications because of loss of effective contraction and atrial stasis.
One surgical method of treating atrial fibrillation by interrupting pathways for reentry circuits is the so-called “maze procedure,” which relies on a prescribed pattern of incisions to anatomically create a convoluted path, or maze, for electrical propagation within the left and right atria. The incisions direct the electrical impulse from the SA node along a specified route through all regions of both atria, causing uniform contraction required for normal atrial transport function. The incisions finally direct the impulse to the AV node to activate the ventricles, restoring normal atrioventricular synchrony. The incisions are also carefully placed to interrupt the conduction routes of the most common reentry circuits. The maze procedure has been found very effective in curing atrial fibrillation. However, not only is the maze procedure is technically difficult to do, it also requires open heart surgery and is very expensive.
Maze-like procedures have also been developed utilizing electrophysiology procedures, which involves forming lesions on the endocardium (the lesions being 1 to 15 cm in length and of varying shape) using an ablation catheter to effectively create a maze for electrical conduction in a predetermined path. The formation of these lesions by soft tissue coagulation (also referred to as “ablation”) can provide the same therapeutic benefits that the complex incision patterns of the surgical maze procedure presently provides, but without invasive, open heart surgery.
In certain advanced electrophysiology procedures, it is desirable to create a lesions around, within, or otherwise adjacent to orifices. For example, as part of the treatment for certain categories of atrial fibrillation, it may be desirable to create a curvilinear lesion around or within the ostia of the pulmonary veins (PVs), and a linear lesion connecting one or more of the PVs to the mitral valve annulus. Preferably, such curvilinear lesion is formed as far out from the PVs as possible to ensure that the conduction blocks associated with the PVs are indeed electrically isolated from the active heart tissue. To do this, a physician must be able to move the ablation catheter tip along a desired path and either deliver ablative energy while slowly dragging the tip along the path, or deliver energy at a number of discrete points along that path. Either way, it is crucial that the physician be able to accurately and controllably move the catheter tip along that path. When ablating around the PVs, however, energy is typically applied along the curvilinear path using a free-hand approach, thereby rendering it difficult to accurately move the catheter tip along that path. More importantly, during the electrophysiology procedure, it is important to prevent inadvertent damage to non-targeted regions, such as the PVs themselves, which could produce stenosis of the PVs. Thus, it has proven difficult to form circumferential lesions using conventional devices to isolate the PVs and cure ectopic atrial fibrillation.
One technique that has recently been developed to address this problem is disclosed in copending U.S. application Ser. No. 10/983,072, entitled “Preshaped Ablation Catheter for Ablating Pulmonary Vein Ostia within the Heart,” which is expressly incorporated herein by reference. In this technique, a proximal section of the distal end of the catheter is formed into a curve and inserted into the pulmonary vein, and then rotated within the pulmonary vein as the ablation catheter tip moves around the ostium in a predictable arc, thereby ensuring that ablations are performed along a desired path on the ostium, while also ensuring that no ablations are performed within the pulmonary vein itself.
While this technique has proven to work fairly well for this intended purpose, it has been discovered that the resiliency of the curve increases the friction between the catheter and the inner surface of the pulmonary vein, thereby causing the curve to grab the inner surface of the pulmonary vein and produce a jerking motion as the curve is rotated within the pulmonary vein. In addition, although ablation lesions can be formed in a predictable manner, such technique does not currently provide a means for verifying proper location of the ablation lesions.
Accordingly, in addition to the need of being able to more efficiently and accurately create circumferential lesions around bodily orifices, such as the ostia of the PVs, there remains a need to be able to allow the curve of a catheter to be more easily rotated within a vessel, as well as a need to provide a means for independently verifying the location of an operative element, such as an tissue ablation element, relative to the ostium of the vessel.